Onyx Pharmaceuticals Inc. on Monday announced that it has begun enrolling for ENDEAVOR trial, a phase 3 head to head comparison trial of Kyprolis (Carfilzomib) in combination with dexamethasone and bortezomib (Velcade) with dexamethasone in patients with relapsed multiple myeloma. I am sharing their press release here,
South San Francisco, CA. — Jul. 02, 2012
Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced today that the company has begun enrollment in the ENDEAVOR trial, a Phase 3 trial evaluating KyprolisTM (proposed brand name for carfilzomib) in combination with dexamethasone, versus bortezomib (Velcade®) with dexamethasone in patients with relapsed multiple myeloma.
“The ENDEAVOR trial is the first head-to-head trial conducted with Kyprolis, and is an important step in the development program,” said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. “The initiation of this trial underscores our commitment to patients with multiple myeloma who are in need of new treatment options beyond the currently available therapies.”
The FDA is currently reviewing a New Drug Application (NDA) for potential accelerated approval of Kyprolis in the United States for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent (IMiD). The Prescription Drug User Fee Act (PDUFA) date for completion of the NDA review by the FDA is July 27, 2012.
Phase 3 Trial Design
The ENDEAVOR (RandomizEd, OpeNLabel, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) trial is an 888 patient study evaluating Kyprolis in combination with dexamethasone, versus Velcade® (bortezomib) with dexamethasone in patients whose multiple myeloma has relapsed after at least one, but not more than three prior therapeutic regimens. The primary endpoint of the trial is progression-free survival. Secondary endpoints include overall survival, overall response rate, duration of response, and safety. Patients will be randomized to receive Kyprolis intravenously (20mg/m2 on days 1 and 2 of cycle 1 only, then 56 mg/m2 subsequently) with low-dose dexamethasone (20mg), versus bortezomib (1.3 mg/m2) with low-dose dexamethasone. Bortezomib can be administered subcutaneously or intravenously at the discretion of the investigator and in accordance with regulatory approval of bortezomib. The study will be conducted at approximately 200 sites worldwide. For information about this study, please visitwww.clinicaltrials.gov under trial identification number NCT01568866.
Onyx Pharma is going ahead with their enrollments for Kyprolis trials and this is real good news for multiple myeloma patients who are running out of options.In addition to ENDEAVOR, Kyprolis is being investigated in,
- ASPIRE trial – A phase 3 clinical trial, evaluating combination of lenalidomide and low dose dexamethasone with/without Kyprolis.
- FOCUS trial – A phase 3 clinical trial, evaluating Kyprolis as single agent in patients with relapsed multiple myeloma.
- Phase 1/2 study by Onyx’s partner Ono Pharmaceutical Co., Ltd, investigating Kyprolis in Japanese patients.
Onyx is awaiting FDA approval for carfilzomib/ Kyprolis.
- Kyprolis’ short-term future to be decided this summer
- Clinical Trials for Multiple Myeloma Patients with Relapsed/Refractory Disease Recruiting Currently
- The Multiple Myeloma Research Foundation and Onyx Pharmaceuticals – Dedicated to better treatments for Multiple Myeloma
- Carfilzomib granted FDA review for use in relapsed and refractory multiple myeloma patients
- Looks like carfilzomib has a trade name: Kyprolis